Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury (BRAINI2)

  • STATUS
    Recruiting
  • End date
    Apr 1, 2025
  • participants needed
    2880
  • sponsor
    Nantes University Hospital
Updated on 4 October 2022
cancer
traumatic brain injury
coma
concussion

Summary

Mild traumatic brain injury (TBI), defined by a Glasgow Coma Scale (GCS) score of 13 to 15, is the cause of many consultations in paediatric emergency departments (1), even though it is a rare cause of acute complication: approximately 10% of children present with intracranial lesions (ICL) on the CT scan and less than 1% require neurosurgical intervention (2). Although ICLs remain a serious complication requiring rapid diagnosis, brain CT scans, the gold standard diagnostic test, cannot be performed routinely because many children would be unnecessarily exposed to ionising radiation associated with an increased risk of cancer (3). In recent years, several clinical decision rules for the management of mTBI have therefore been developed with the aim of identifying children at high or very low risk of ICL in order to better target CT scan indications. Despite this, the rate of CT scans performed has remained high, up to 35%, and has not decreased with the application of these clinical decision rules (4).

Furthermore, even though the majority of children and adolescents recover quickly after mTBI, nearly 30% will present symptoms such as headaches, dizziness, asthenia, memory, concentration or sleep disorders persisting beyond one month with a possible impact on their quality of life (5). Thus, there is a need to develop new strategies to (i) limit the use of CT scans while minimising the risk of late diagnosis of ICL, (ii) identify children with a higher risk of adverse outcome and/or post-concussive symptoms.

One of the most promising strategies is the use of brain-based blood biomarkers. This study therefore aims to provide new knowledge on two of them, GFAP and UCH-L1 (6,7), in particular by using an automated test combining them (the VIDAS® TBI test developed by bioMérieux) in order to improve the management of CT in the paediatric population at the diagnostic and prognostic levels.

Details
Condition Traumatic Brain Injury
Treatment Biomarkers research
Clinical Study IdentifierNCT05413499
SponsorNantes University Hospital
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Children and adolescents <18 years old Consent from one of the parents of the child or from
holder of parental responsibility Consent from the child or adolescent Parental affiliation
with an appropriate health insurance system
TBI population
Admission within 24 hours of the injury
Ability to follow-up by telephone, mail or email
For the mTBI group
GCS score of 13-15 on admission
Indication for cerebral CT scan according to national or local guidelines or
the in-charge physician OR diagnosis of concussion consistent with the
fourth Zurich consensus statement (9) . Concussion was defined as a complex
pathophysiological process caused by a direct blow to the head, face, neck
or elsewhere on the body with an impulsive force transmitted to the head
(which may or may not have involved loss of consciousness), resulting in a
brain injury with one or more symptoms in one or more of the following
clinical domains: somatic, cognitive, emotional or behavioural, or sleep. To
objectively help diagnose concussion, the validated Acute Concussion
Evaluation (ACE) questionnaire (10) for children with mTBI will be used, the
presence of ≥ 1 symptom on the ACE defines concussion
For the moderate or severe TBI group
GCS score of 3-12 on admission
Indication for cerebral CT scan according to national or local guidelines or
the in-charge physician
Non-TBI control paediatric population
Admission for any reason other than TBI
Indication of blood sampling for their routine management
GCS score of 15
Otherwise healthy, i.e. without chronic pathology

Exclusion Criteria

TBI population
Time of injury unknown or exceeding 24 hours
Blood sampling not possible within 24 hours after the injury or 6 hours after the
CT scan, if applicable
Penetrating brain injury with skull fracture
Pre-existing neurological disorders affecting the assessment of neurological
outcome, seizure disorder/epilepsy, brain tumour, history of neurosurgery
stroke, encephalopathy
Venepuncture not feasible
Pregnant woman
Intoxication
No clear primary mechanism of trauma
No possibility for transferring CT scan images to the centralised platform in
case of neuroimaging only performed in an outside hospital before transfer
Participation in another interventional research study
Non-TBI control paediatric population
Pre-existing neurological disorders, seizure disorder/epilepsy, brain tumour
history or indication of neurosurgery, stroke, encephalopathy
History of TBI
Orthopaedic trauma or surgery within the last month
Suspected meningitidis or encephalitis
Venepuncture not feasible
Pregnant woman
Intoxication
Participation in another interventional research study
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